Kornimate/medical-research-clean huggingface dataset:
surgery checklist and process improvement surrounding endoscopic sinus surgery

Conditions: Chronic Rhinosinusitis

Summary: the purpose of this clinical trial is to evaluate the effectiveness of a new surgical checklist in the setting of sinus surgery for patients with chronic rhinosinusitis (crs) and to measure the frequency of compliance by surgical personnel at ohsu with specific daily safety protocols before and after introduction of the checklist. the investigators hypothesized that the use of an ess specific surgical checklist will improve the frequency of compliance by surgical personnel at ohsu to internal safety concerns and protocols.

a total of 200 unidentified, non-randomized endoscopic sinus surgery cases will be observed and reviewed by research personnel (t.l.s, j.c.) within the oregon sinus center, located within the center for health and healing on the south waterfront campus of ohsu, under the direction of timothy l. smith, md, mph (pi). the first 100 surgical cases will be evaluated as "pre-intervention" cases by research personnel while the second 100 surgical cases will be evaluated as "post-intervention" cases after the introduction and discussion of the surgical checklist to operating room staff.

Eligibility criteria:
inclusion criteria: * crs defined by 2007 adult sinusitis guidelines.13 * unidentified adult patients electing endoscopic sinus surgery for the treatment of crs. exclusion criteria: * unable to complete surgical procedures due to perioperative complications.

Keywords: sinusitis disease chronic sinonasal
surveillance of safety and efficacy of wilate in patients with von willebrand disease

Conditions: Von Willebrand Disease

Summary: this is an observational study, hence there is no study hypothesis


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of von willebrand disease who have been prescribed wilate
the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine

Conditions: Hypertension; Hyperlipidemia

Summary: a randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

a randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

Eligibility criteria:
inclusion criteria: * 19\~55 years healthy male * body weight is over 55kg, the result of body mass index(bmi) is not less than 18 kg/m2 , no more than 27 kg/m2 * subjects who agree to keep contraceptive methods during the clinical trial. exclusion criteria: * subjects who are allergic to investigational drug. * subjects who have a medical history which can affect the clinical trial. * hypertension(systolic bp ≥ 150mmhg or diastolic bp ≥ 100mmhg), hypotension(systolic bp ≤ 100mmhg or diastolic bp ≤ 65mmhg) * liver enzyme (ast, alt) level exceeds the maximum normal range more than one and a half times.
a study assessing the safety and efficacy of adding ipatasertib to paclitaxel treatment in participants with breast cancer that has spread beyond the initial site, and the cancer does not have certain hormonal receptors

Conditions: Breast Neoplasms

Summary: this multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mtnbc), as measured by progression-free survival (pfs) in all participants and in participants with phosphatase and tensin homolog (pten)-low tumors.


Eligibility criteria:
inclusion criteria: * histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent * eastern cooperative oncology group (ecog) performance status of 0 or 1 * availability of a representative formalin-fixed, paraffin-embedded (ffpe) tumor specimen, required prior to randomization * measurable disease, according to the recist v1.1 * adequate hematologic and organ function within 14 days before the first study treatment * for female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment exclusion criteria: * any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (\>/=) 6 months prior to cycle 1 day 1. locally recurrent disease must not be amenable to resection with curative intent * any radiation treatment to metastatic site within 28 days of cycle 1, day 1 * known human epidermal growth factor receptor 2 (her2) positive, erythrocyte receptor (er) positive, or progesterone receptor (pr) positive breast cancer * previous therapy with akt, pi3k, and/or mtor inhibitors * major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study * known presence of the brain or spinal cord metastasis, as determined by computed tomography (ct) or magnetic resonance imaging (mri) evaluation during screening or prior radiographic assessments
safety and efficacy of bay94-9027 in previously treated male children with haemophilia a

Conditions: Hemophilia A

Summary: hemophilia a is an inherited blood disorder in which one protein, factor viii, needed to form blood clots is missing or not present in sufficient levels. hemophilia a causes the clotting process to be slowed and the person experiences bleeds causing serious problems that could lead to disability. the current standard treatment for severe hemophilia a is infusion of fviii to stop bleeding, or regular scheduled treatment to prevent bleeds from occuring. due to the short half-life of fviii, prophylaxis may require treatment as often as every other day. in this trial safety and efficacy of a long-acting recombinant factor viii molecule is being evaluated in 50 male subjects, \< 12 years of age, with severe hemophilia a. these subjects will receive open label treatment with long-acting rfviii for approximately 6 months (or longer until 50 exposure days) on a regular schedule at least once every 7-days. doses and dose intervals may be adapted to the subject's clinical need. a second group of patients will receive open label treatment with the same drug for 12 weeks on a regular schedule of 2x/week. patients will attend the treatment center for routine blood samples and will be required to keep an electronic diary. subjects will be offered participation in an optional extension study to collect observations for at least an additional 50 exposure days.


Eligibility criteria:
inclusion criteria: * males \< 12 years of age * subjects with severe hemophilia a * previously treated with fviii for \> 50 exposure days exclusion criteria: * subjects with current evidence of or history of inhibitors to fviii * any other inherited or acquired bleeding disorder * platelet counts \< 100,000/mm\^3 * creatinine \> 2x the upper limit of normal * aspartate aminotransferase (ast) / alanine aminotransferase (alt) \> 5x the upper limit of normal

Keywords: hemophilia a factor viii prophylaxis pediatric
use of the percsys microstent device to alleviate ureteral stone symptoms and hydronephrosis

Conditions: Kidney Stones

Summary: kidney stones cause severe pain. patients with a stone lodged in the ureter (the tube that drains the bladder), require urgent treatment with a stent to relieve the blockage. this tube, or ureteral stent, gives the patient relief until they can have their stone treated. this study is to evaluate a new type of ureteral stent to relieve pain from kidney stones. this stent is designed to drain the kidney and unlike other ureteral stents, is also designed to widen the ureter to help the stone pass on its own.

this study is to evaluate a new type of ureteral stent to relieve kidney obstruction from a stone lodged in the ureter. this stent would be placed when a patient presents with pain in the emergency room or clinic in a patient that has no signs of infection. it is designed to continue drainage of the kidney and unlike other ureteral stents, is also designed to help dilate the ureter to facilitate spontaneous stone passage. this means the stent may also be therapeutic and the patient would be less likely to undergo another procedure to have the stone removed. research performed at the stone centre at vgh shows that in ex vivo pig kidneys, this stent provides very good urinary drainage of the kidney. this has been published in a peer-reviewed journal (lange d, hoag na, poh bk, chew bh. drainage characteristics of the 3f microstent using a novel film occlusion anchoring mechanism. j endourol. 2011 jun;25(6):1051-6.).

Eligibility criteria:
inclusion criteria: 1. perforation of the urinary tract; 2. acute hemorrhage; 3. tissue trauma; 4. edema; 5. submucosal tunneling of guidewire or device during advancement; and 6. protein encrustation of the device. exclusion criteria: 7. infection; 8. hemorrhage; 9. complications associated with the use of anesthesia, 10. perforation of the urethra or bladder, 11. scarring or stricture of the urethra; and 12. urinary retention due to urethral edema.

Keywords: kidney stones ureteral stones stent
the use of amber glasses in improving sleep

Conditions: Sleep Disturbance; Insomnia

Summary: the use of amber glasses will aid the patient to fall asleep without the need for the use of hypnotic medication.

sleep disturbance and insomnia is extremely common and affects up to 30% of adults at any given time. moreover, sleep disturbance is known to be particularly prevalent in patients suffering from mental illness including affective disorders, schizophrenia, anxiety (baglioni, 2016). we hypothesise that the use of amber glasses will aid the time taken to fall asleep without the need for the use of hypnotic medication.a prospective study looking at 15 new patients admitted to one mental health ward will be undertaken. data will be collected on twice weekly basis on the patient's use of: amber glasses alone, hypnotic medication alone or both. hypnotic medication will include sedating antihistamines, benzodiazepines and non-benzodiazepine hypnotics such as zopiclone. medication prescribed for dual purpose will be assumed to be used for the treatment of insomnia if given after 2300 hours. each patient will be enrolled for a period of 4 weeks and the review of use and suitability will take place in ward review meetings. sleep quality will be assessed using the pittsburgh sleep quality assessment tool at baseline and at the 2 and 4 weeks. at the end of the study period, percentage use of amber glasses and zopiclone will be used to compare against a historical average of hypnotic use for the most recent 15 admissions over a similar 4 week period.

Eligibility criteria:
inclusion criteria: * age over 18 years * male or female gender * presentation of mental illness (of psychotic nature, severe depression or anxiety) * able to provide informed consent exclusion criteria: * patient does not consent * high risk assessment of self-harm or harm to others
internet-delivered psychodynamic therapy for depression and anxiety disorders

Conditions: Depression; Anxiety

Summary: the overall aim of this study is to develop and test a psychodynamic internet-delivered psychological treatment for patients with major depression and/or anxiety disorders and compare its efficacy to an active control group.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of major depressive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, depressive disorder nos or anxiety disorder nos * 10 or higher on the phq-9 or on the gad-7 at pre-treatment exclusion criteria: * primary diagnosis of obsessive compulsive disorder or post-traumatic stress disorder * severe psychiatric condition (e.g. psychosis or bipolar disorder) * alcohol abuse (more than 16 on the audit) * suicidal (measured in diagnostic interview) * changed medication during the last three months
responses to a comfort meal in functional dyspepsia

Conditions: Functional Gastrointestinal Disorders

Summary: background. dyspeptic patients tolerate smaller meal loads than healthy subjects, but it is not known whether and to what extent symptoms relate to abnormal homeostatic or hedonic components of perception. methods. parallel studies in patients with symptoms induced by meals (fulfilling rome iv criteria of postprandial dyspepsia) and sex- and age-matched healthy subjects. participants will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 4 h after breakfast. studies will be conducted in a quiet, isolated room with participants sitting on a chair. participants will ingest a probe meal up to the level of maximal satiation. the probe meal will be served stepwise (112 kcal every 5 min). perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.


Eligibility criteria:
inclusion criteria for patients with functional dyspepsia: * rome iv criteria for functional dyspepsia inclusion criteria for healthy subjects * absence of digestive symptoms exclusion criteria for all participants: * history of anosmia and ageusia * alcohol abuse * psychological disorders * eating disorders inclusion criteria for healthy subjects: * non-obese exclusion criteria: * history of gastrointestinal symptoms * prior obesity * use of medications * history of anosmia and ageusia * current dieting * alcohol abuse * psychological disorders * eating disorders

Keywords: meal ingestion postprandial responses hedonic sensations homeostatic sensations functional dyspepsia
head repositioning accuracy during experimental neck pain

Conditions: Healthy; Neck Pain

Summary: this study investigates if/how an experimentally applied neck muscle pain influences head repositioning error in healthy participants.

healthy volunteers will participate in a single session study with a crossover design. during the study healthy participants will be randomized to either receive a injection of hypertonic saline (painful injection) or isotonic saline (control injection) in a neck muscle. head repositioning accuracy will be assessed with and without performing a cognitive task.

Eligibility criteria:
inclusion criteria: * healthy men and women aged 18-50 years * right handed * able to speak, read and understand danish or english * normal pain free neck and shoulder range of motion exclusion criteria: * pain from the neck or shoulder area * prior surgery in neck or shoulder * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * self reported neurologic, musculoskeletal or mental illnesses
first-in-human safety and immunogenicity study of scb-1019 and scb-1019t in healthy adults

Conditions: Respiratory Syncytial Virus Vaccination

Summary: first-in-human safety and immunogenicity study of scb-1019 and scb-1019t in healthy adults

a phase 1, placebo-controlled, randomized, observer-blind, first-in-human study to describe the safety, reactogenicity and immunogenicity of a bivalent recombinant rsv vaccines (scb-1019 and scb-1019t) in healthy adults

Eligibility criteria:
inclusion criteria: 1. male and female participants 60 to 85 years of age at the screening visit. 2. individuals willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures. 3. individuals willing and able to give an informed consent, prior to screening. healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included. exclusion criteria: 1. acute disease or fever (≥38°c) at time of vaccination. 2. history of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines. 3. any progressive unstable or uncontrolled clinical conditions. 4. any progressive or severe neurologic disorder, seizure disorder, or history of guillain-barré syndrome. please refer to protocol for full list of inclusion and exclusion criteria.

Keywords: respiratory syncytial virus vaccination
acute effect of exenatide on brain glucose metabolism

Conditions: Impaired Glucose Tolerance (IGT); Diabetes

Summary: this research study will examine brain glucose metabolism after an overnight fast to determine the effect of exenatide on brain glucose metabolism and lipid metabolism.

this study will elucidate if exenatide has an effect on brain glucose metabolism. this will be accomplished by measuring the rate of glucose binding in various brain regions by positron emission tomography (pet) after glucose load with exenatide injection and compare it with placebo injection measured in the same subject. the changes will be compared with peripheral and hepatic glucose metabolism and lipolysis.

Eligibility criteria:
inclusion criteria: 1. males age 18-65 years old 2. patients must have body mass index (bmi) between 25 and 40 kg/m2 3. 2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes. 4. patients must have bmi of 25-40 kg/m2 5. patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study. 6. only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included. 7. patients must have the following laboratory values: * hematocrit ≥ 34 vol% * serum creatinine\* ≤ 1.5 mg/dl in males and * aspartate aminotransferase (ast) serum glutamic oxaloacetic transaminase (sgot): ≤ 2.5 times upper limit of normal * alanine aminotransferase (alt) serum glutamic pyruvic transaminase (sgpt): ≤ 2.5 times upper limit of normal * alkaline phosphatase ≤ 2.5 times upper limit of normal * if serum creatinine is ≤ 1.5 mg/dl in males, the pi can grant an exception and not exclude the patient if the glomerular filtration rate (gfr) is \>70 ml/min exclusion criteria: patients are excluded from participation in the study if they meet any of the following criteria: 1. patients with major chronic illness (cancer, liver, kidney, cardiovascular disease) 2. patients with bmi over 40 and under 25 3. patient with age below 18 yrs and over 65 yrs 4. female subjects 5. patients with type 1 diabetes 6. patients treated for type 2 diabetes 7. subjects with normal glucose tolerance (ngt)

Keywords: impaired glucose tolerance (igt) diabetes
the effect of desflurane on myocardial function in patients undergoing coronary artery bypass grafting

Conditions: Coronary Artery Bypass Graft Redo; General Anesthetic Drug Adverse Reaction

Summary: this study is to assess the effect of desflurane on myocardial function in patents who underwent coronary artery bypass grafting.

desﬂurane, one of the third-generation inhaled anesthetics, is introduced in clinical practice in 1990s. decades of clinical use has provided evidence for desﬂurane's safe and efﬁcacious use as a general anesthetic. compared with other volatile anesthestics, it has several characteristics: lower blood and lipid solubility, more stable in vitro and the lowest in vivo metabolism. its particular low fat solubility properties promote rapid equilibration and rapid elimination at the end of anesthesia which reduces slow compartment accumulation and promotes predictable emergence, early extubation, and the ability to rapidly transfer patients from the operating room to the recovery unit. in addition, several investigations found that patients with desflurane anesthesia recovered their protective airway reﬂexes and awakened to a degree sufﬁcient to minimize the stay in the high dependency recovery area. a burgeoning body of investigations has shown that desflurane can directly act on myocardial and vascular functions. desflurane has coronary vasodilative effects in in situ canine hearts which is comparable to sevoflurane does. although it is controversial regarding to the effect of desflurane on myocardial excitation-contraction coupling and electrophysiologic behavior, a elaborated study found desflurane induced a positive inotropic effect in rat myocardium in vitro compared with isoflurane. a recent study suggested that desflurane decreased right ventricular contractility much less and maintained the right over left pressures ratio at more favorable values compared with sevoflurane. furthermore, substantial investigations found that clinically relevant concentration desflurane preconditioning or postconditioning could protect myocardium from ischemia-reperfusion in mammalian animal models or isolated human cardiac tissues. however, it is unclear whether desflurane can provide protection for patients with coronary artery disease. therefore, this study is designed to investigate the effect of desflurane on myocardial function in patents who underwent coronary artery bypass grafting.

Eligibility criteria:
inclusion criteria: 1. diagnosed with cad 2. asaⅱ～ⅲ - exclusion criteria: 1. left ventricular ejection fraction \<40% 2. left ventricular aneurysm 3. acute myocardial infarction in latest two weeks, atrial fibrillation 4. associated vascular diseases, severe systemic diseases involving the renal and hepatic systems 5. respiratory disease( forced vital capacity less than 50% of predicted values ) 6. preoperative left bundle branch block -

Keywords: desflurane myocardial function coronary artery bypass surgery
diagnostic accuracy of bedside ultrasonography in the management of the shoulder dislocations

Conditions: Shoulder Dislocation

Summary: shoulder dislocation is a common clinical presentation in the emergency department, comprising about 50 percent of all major joint dislocations. in the standart management of shoulder dislocations physicians generally need to see pre and post reduction x ray graphics. ultrasonography is harmless way of evaluating shoulder and may be used in the management of the shoulder dislocations instead of the x ray evaluations.

shoulder dislocation is a common clinical presentation in the emergency department, comprising about 50 percent of all major joint dislocations. in the standard management of shoulder dislocations physicians generally need to see pre and post reduction x ray graphics. ultrasonography is harmless way of evaluating shoulder and may be used in the management of the shoulder dislocations instead of the x ray evaluations.recent literature has demonstrated the superiority of point-of-care ultrasonography (pocus) in detecting both anterior and posterior shoulder dislocations, making it another rapidly evolving tool to improve accuracy, decrease error, and improve efficiency. the aim of the study is to evaluate the accuracy and clinical usability of ultrasonography in the management of the shoulder dislocations.

Eligibility criteria:
inclusion criteria: * all patients over 14 years with suspected shoulder dislocation * accept to be participating exclusion criteria: * patients under 15 years of age * diagnosed before pocus evaluation * open fracture dislocations of the shoulder

Keywords: pocus ultrasonography glenohumeral dislocation